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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Achilles +; Achilles Express; Achilles Express Ultrasonometer; Achilles Insight; Achilles Insight Ultrasonometer
Classification Name: BONE SONOMETER
Product Code: MUA
Device Class: 2
Regulation Number: 892.1180
Medical Specialty: Radiology
Registered Establishment Name: GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Registered Establishment Number: 2183066
Owner/Operator Number: 9912004
Establishment Operations: Specification Developer